Validation Engineer

Virtue America; United States; On-site; USD 65,000 - 90,000; Full time

Job summary

Virtue America is seeking an entry-level Validation Engineer to support qualification, validation, and compliance activities across pharmaceutical manufacturing and biotech operations in the United States.

The role emphasizes IQ/OQ/PQ execution, process and cleaning validation, documentation, and data integrity within a regulated manufacturing environment, offering growth in cGMP/compliance knowledge.

Qualifications

• Bachelor's or Master's degree in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, Biomedical Engineering, Mechanical Engineering, Chemistry or related field.
• Basic understanding of pharmaceutical validation principles and qualification lifecycle.
• Familiarity with IQ, OQ, PQ, process validation and equipment qualification concepts.
• Knowledge of cGMP, GDP, SOPs, and pharmaceutical quality documentation.
• Awareness of risk assessments, deviation management, change control, and CAPA processes.
• Ability to interpret technical documents, equipment specifications, test results, and validation records.
• Strong analytical thinking, problem-solving, organization, and attention to detail.
• Proficiency in Microsoft Word and Excel for protocol preparation, data tracking, and reporting.
• Good written and verbal communication skills with the ability to work across technical teams.
• Preferred: Academic projects, internships, or practical exposure to pharmaceutical manufacturing, laboratory equipment, quality assurance, or validation documentation.

Responsibilities

• Assist with qualification activities for pharmaceutical manufacturing equipment, laboratory instruments, and supporting systems to verify operation per approved specifications.
• Support the preparation and review of validation plans, test protocols, execution records, and final reports under guidance of senior personnel.
• Participate in IQ, OQ, and PQ activities to confirm equipment installation, functionality, and performance.
• Assist with collecting process data, reviewing manufacturing parameters, and documenting evidence that production processes meet requirements.
• Help organize sampling records, review cleaning procedures, and document cleaning validation results.
• Support calibration verification, instrument qualification, and documentation for analytical equipment.
• Assist in identifying validation requirements based on equipment criticality, product quality risks, and intended system use.
• Document deviations and CAPA, assist with investigations, and track corrective actions.
• Help assess proposed equipment, process, and system changes for requalification or revalidation needs.
• Follow cGMP, GDP, SOPs, and regulatory requirements; maintain ALCOA+ data integrity.

Education

Pharmaceutical Sciences

Chemical Engineering

Biotechnology

Biomedical Engineering

Mechanical Engineering

Chemistry

Job description

We are seeking a detail-oriented and motivated Entry-Level Validation Engineer to support qualification, validation, and compliance activities across pharmaceutical manufacturing and biotechnology operations. The selected candidate will assist in verifying that equipment, manufacturing processes, facility systems, and laboratory instruments consistently meet established performance requirements and quality standards. This position is suitable for recent graduates interested in pharmaceutical quality systems, engineering validation, and regulated manufacturing environments.

Key Responsibilities:

• Equipment Qualification: Assist with qualification activities for pharmaceutical manufacturing equipment, laboratory instruments, and supporting systems to verify that they operate according to approved specifications.
• Validation Protocol Development: Support the preparation and review of validation plans, test protocols, execution records, and final reports under the guidance of senior validation personnel.
• IQ/OQ/PQ Execution: Participate in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities to confirm equipment installation, functionality, and performance.
• Process Validation: Assist with collecting process data, reviewing manufacturing parameters, and documenting evidence that production processes consistently meet defined requirements.
• Cleaning Validation Support: Help organize sampling records, review cleaning procedures, and document results associated with cleaning validation studies.
• Laboratory Instrument Validation: Support calibration verification, instrument qualification, and performance documentation for analytical and laboratory equipment.
• Risk Assessment: Assist in identifying validation requirements based on equipment criticality, product quality risks, and intended system use.
• Deviation and CAPA Support: Document unexpected test results, assist with investigation records, and track corrective and preventive actions related to validation activities.
• Change Control Management: Help assess proposed equipment, process, and system changes to determine whether requalification or revalidation may be necessary.
• Regulatory Compliance: Follow current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), internal SOPs, and applicable regulatory requirements.
• Documentation and Data Integrity: Maintain accurate, traceable, and organized validation records in accordance with data integrity principles, including ALCOA+.
• Cross-Functional Coordination: Collaborate with Quality Assurance, Quality Control, Manufacturing, Engineering, and Maintenance teams to support validation schedules and project deliverables.

Required Skills:

• Bachelor's or Master's degree in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, Biomedical Engineering, Mechanical Engineering, Chemistry, or a related life sciences or engineering discipline.
• Basic understanding of pharmaceutical validation principles and qualification lifecycle activities.
• Familiarity with IQ, OQ, PQ, process validation, and equipment qualification concepts.
• Knowledge of cGMP, GDP, SOPs, and pharmaceutical quality documentation.
• Awareness of risk assessments, deviation management, change control, and CAPA processes.
• Ability to interpret technical documents, equipment specifications, test results, and validation records.
• Strong analytical thinking, problem-solving, organization, and attention to detail.
• Proficiency in Microsoft Word and Excel for protocol preparation, data tracking, and reporting.
• Good written and verbal communication skills with the ability to work across technical teams.
• Preferred: Academic projects, internships, or practical exposure to pharmaceutical manufacturing, laboratory equipment, quality assurance, or validation documentation.